As any ophthalmic ASC clinician knows, compounded ophthalmic medications are often the only option for many patients and surgical cases. Yet, just as with any other drug, there can be significant risks associated with using them.

As a result, ASCs must be certain they are partnering with a compounding pharmacy that demonstrates best practices with respect to producing and distributing only the safest and highest-quality compounded ophthalmic medications.

We asked industry experts for their best advice on identifying and working with compounding pharmacies. They were unanimous in saying that great care should be taken when choosing to partner with such facilities.

“It is a great deal of work to find a compounding facility that is right for you,” says Todd Albertz, vice president, Surgical and Specialty Services at the Cincinnati Eye Institute/Northmark Pharmacy in Cincinnati, OH. “If you find one that meets your standards, provides excellent customer service, and is priced competitively, stick with it.”

“The surgeon knows what medications to use based on his training, experience, and preference, and compounding pharmacists can be instrumental in offering ophthalmologists options to commercially available products when necessary,” agrees Brian Williamson, PharmD, managing director of The Williamson-Rockers Group, a compounding pharmacy consulting firm in Wichita, KS. “However, just because something can be compounded doesn’t necessarily mean that it should be compounded.”

Two Types of Compounding Pharmacies

In the United States, two types of providers formulate and distribute compounded ophthalmic medications: traditional compounding pharmacies and human drug compounding outsourcing facilities. Under the U.S. Food, Drug, and Cosmetic (FD&C) Act, traditional pharmacies are called 503A pharmacies, and they must adhere to USP General Chapter <797>, Pharmaceutical Compounding: Sterile Preparations.

“The chapter is a national minimum standard for processing, testing, and verification of compounded sterile preparations (CSPs),” Williamson says. “USP <797> provides best practice guidance on preventing microbial contamination and other variances in CSPs, regardless of setting (e.g., hospitals, community pharmacies) or who is performing the compounding (pharmacists, nurses, pharmacy technicians, physicians, or others). It should be noted that only 32 state boards of pharmacy require adherence to USP <797>.”

The second type, human drug compounding outsourcing facilities, are known as 503B facilities under the FD&C Act. They can manufacture compounded products in batches, and prescriptions may or may not be required. These pharmacies must adhere to current Good Manufacturing Practices (cGMP), the same standards that are applied to pharmaceutical manufacturers, says Williamson.

“The cGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have,” he says.

Signs of High-quality Compounding Pharmacies

Our experts agree that high-quality compounding pharmacies share certain characteristics in common. These include the following:

• They go beyond the basics. “A high-quality compounder treats the regulations as a minimum standard, constantly seeks to improve operations and processes, and has a sterile compounding clean room that operates under a constant state of control,” says Greg Rockers, RPh, managing director and Williamson’s partner in the Williamson-Rockers Group. “This also means trending all excursions, adverse events, and customer complaints to help prevent repeat issues that could potentially harm patients.”
• They know their stuff. Knowledge and experience are critical, not just with sterile compounding in general, but also with the specific products used. “We recommend a compounding pharmacist with strong clinical skills,” Williamson says.
• They put the customer first. Most ophthalmic ASCs don’t have dedicated pharmaceutical buyers, Rockers says, and often, the nurse in the OR earlier in the day is the same one who has to order medication before going home. “The last thing you want is to have to wait for a call back or make multiple calls looking for the answers you need,” he says. “High-quality customer service is the ability to talk to a ‘real person’ the first time you call, a person who is empowered to solve your problem in a timely manner; immediate access to a pharmacist for clinical questions; and product consistently in stock.”

Signs of Poor-quality Compounding Pharmacies

Conversely, ASC operators should watch for tip-offs to poor-quality compounding pharmacies. Some examples of these include:

• They lack accreditation. “Look for reports from pharmacy boards and accreditation organizations,” Albertz says. “If a pharmacy isn’t accredited, there may be a good reason they aren’t.”
• They don’t make you feel welcome. “Compounders who are not transparent or who do not allow on-site visits to their facilities should raise concern,” Rockers says. “In fact, if a compounder isn’t willing to allow an auditor to review the facility, that compounder and facility should be immediately removed from consideration.”
• They push their low prices. Be wary of compounders that compete on price.

“It takes significant resources to comply with regulations and produce quality products,” Williamson says. “Do you really want the cheapest compounder? History has clearly shown us this approach is not in your or your patients’ best interest. The dollar spend on compounded products in the ASC is/are relatively small, but the risk is incredibly large.”

Strategies to Identify and Work with Compounding Pharmacies

It’s up to ASC operators and clinicians to ensure they’re selecting and working with reliable, high-quality compounding pharmaceutical facilities. But how do you do that? Through a solid vetting and auditing process, both at the outset and throughout your relationship with the compounding facility. All three of our experts stress the importance of exercising due diligence from the very beginning.

“The single best way ASCs can protect their patients is to thoroughly qualify the compounding pharmacies and outsourcing facilities they choose to work with,” says Rockers.

Albertz agrees, recommending that ASC operators and clinicians visit prospective facilities. “The best way to determine if a pharmacy is right for you is to tour it yourself, talk to the staff, see their policies and procedures, and review their documents,” he says. Albertz also recommends checking state pharmacy board reports and reviewing any citations the pharmacy may have received.

“Pharmacies are reviewed periodically and reports are submitted based on findings. If a pharmacy has major deficiencies, then this may not be a good facility with which to do business,” Albertz says. Another smart step at the outset is to request and check multiple client references, and to request copies of the latest reviews by reputable accreditation organizations, such as the Pharmacy Compounding Accreditation Board. Prospective pharmacies should maintain accreditation with such organizations, most of which review their members every 3 years, he says. Albertz also advises requesting third-party testing records of medications the pharmacy provides its customers and to ensure the pharmacy will agree to supply you with the same records for each lot of medications produced for your surgery center.

Develop a Working Relationship

Once your surgery center has on-boarded a compounding pharmacy (or two — more about that later), it’s a good idea to stay on top of the relationship through regular contact and quality audits, our experts say.

“The vast majority (if not all) CSP tragedies can be avoided if the ASC conducts rigorous, ongoing, and unannounced quality audits of their compounding providers,” Williamson says.

Most ASC operators, however, don’t have the time or expertise to conduct such audits. One option, he says, is to see if your group purchasing organization (GPO) has an approved compounding provider on contract.

“Another option is to hire an expert to audit potential compounding providers to free up the ASC operators to do what they do best — run their facilities and provide excellent patient care,” Rockers says, noting that compounding experts can be found by asking the ASC’s consultant pharmacist for a reference or checking with the surgical center’s GPO to see if it has auditors on contract.

According to Rockers, this auditor should be someone who has worked in the sterile compounding industry and has specific experience in compounding sterile ophthalmic products. He or she should meet the provider’s management team (owner, pharmacists, operations lead, and quality team); tour the physical plant; review its Standard Operating Procedures (SOPs), including its SOPs for recalls, investigations, and Corrective Actions and Preventative Actions; review its training, equipment validation, qualification and certification, and compounding records; and review its recent regulatory inspection results and its remediation plans.

This person should also conduct thorough audits before ordering product and show up unannounced at least annually, Rockers says.

“Again, the spend on compounded products in the ASC is relatively small, but the risk is incredibly large,” Williamson adds. “ASC operators should spend time and resources performing risk assessments of their CSP policies.”

Additional Steps ASCs Should Take

Besides looking for pharmacies that demonstrate best practices and performing audits, experts advise ASC administrators to regularly ask for product test results (sterility, endotoxin, and potency at minimum) that comply with the USP <797>/cGMP requirements as well as quarterly quality reports that show a commitment to continuous quality improvement.

“Be wary of simply receiving test results and quality reports and placing them in a file,” Rockers says. “Testing must be performed appropriately by qualified laboratories, and quality reports must indicate that the compounder has a solid handle on risk management and quality improvement activities.”

Second, he and Williamson recommend that ASCs formalize and implement a written quality agreement with their compounding pharmacy.

“Remember, the compounder is working for you and the safety of your patients,” Rockers says. “ASCs have the obligation to determine what type of products and what level of quality is acceptable. The ASC should determine the acceptance criteria for incoming CSPs and how to reject products that do not meet the agreed upon criteria. We recommend that ASCs engage in a quality agreement with selected compounding partner(s).”

Albertz adds that the ASC-pharmacy relationship requires near-continuous attention to maintain the highest level of quality and to prevent the kind of mistakes that can endanger patients’ overall health and vision. The onus for that attention, he says, ultimately lies with the ASC.

“It is your responsibility to continually monitor the pharmacy, and ask for periodic reports from the pharmacy board or accreditation organizations, so you’re sure they are maintaining the standards you expect,” he says.

Always Have a Back Up Ready

It is partly for that reason that Rockers and Williamson also recommend vetting more than one pharmacy, so that your center isn’t caught unprepared in the event of unexpected medication shortages or other emergencies.

“Continuity of supply is critical,” Rockers says. “Once you have qualified your compounding provider, you do not want to have to repeat that work multiple times a year because your compounder has run short of the medication you need. We recommend having a backup compounder vetted, so if you have to switch providers, you can do so quickly and with confidence.” ■